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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

17 May 2018 EMA/309956/2018 Human Medicines Evaluation Division

List of nationally authorised medicinal products

Active substance(s): losartan

Procedure No.: PSUSA/00001912/201709

List of nationally authorised medicinal products EMA/309956/2018 Page 2/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

LOSARTAN EG 100 mg, comprimé pelliculé not available NL34600

EG LABO LABORATOIRES EUROGENERICS FR

Losartankalium ”Actavis”, filmovertrukne tabletter DK/H/0922/002 38576 ACTAVIS GROUP PTC EHF. DK Losartan Actavis 25 mg filmdrasjerte tabletter DK/H/0922/002 06-4246 ACTAVIS GROUP HF. NO Losartan Actavis 25 mg filmdragerade tabletter DK/H/0922/002 24054 ACTAVIS GROUP HF. SE Losartan Actavis, 25 mg õhukese polümeerikattega tabletid DK/H/0922/002 545407 ACTAVIS GROUP HF. EE COZAAR® 50 mg filmom obložene tablete not available HR-H-243903537 MERCK SHARP & DOHME D.O.O. HR COZAAR® 100 mg filmom obložene tablete not available HR-H-174024498 MERCK SHARP & DOHME D.O.O. HR COZAAR® 50 mg, comprimés pelliculés NL/H/1457/002 1995040196 MSD BELGIUM BVBA/SPRL LU COZAAR® 100 mg, comprimés pelliculés NL/H/1457/003 2007019153 MSD BELGIUM BVBA/SPRL LU COZAAR® 12,5 mg, comprimés pelliculés NL/H/1457/001 1999060006 MSD BELGIUM BVBA/SPRL LU COZAAR® 2,5 mg/ml, poudre et solvant pour suspension buvable NL/H/1457/004 2009030031 MSD BELGIUM BVBA/SPRL LU Kaliumlosartan Sandoz 25 mg, filmomhulde tabletten not available RVG 31868 SANDOZ B.V. NL Losarix 25 mg Filmtabletten DE/H/1059/001 69470.00.00 HEXAL AG DE Losartan HEXAL 75 mg Filmtabletten not available 60875.00.00 HEXAL AG DE Losartan 75 - 1 A Pharma not available 60876.00.00 1 A PHARMA GMBH DE Losartan HEXAL 25 mg Filmtabletten not available 60867.00.00 HEXAL AG DE Losartan 25 - 1 A Pharma not available 60868.00.00 1 A PHARMA GMBH DE Lotanos 100mg Film-coated Tablets not available PA0711/123/005 ROWEX LTD IE Lotanos 50mg Film-coated Tablets not available PA0711/123/003 ROWEX LTD IE Losartan Aurobindo 25 mg filmdragerade tabletter NL/H/3056/001 50998

AUROBINDO PHARMA (MALTA) LIMITED SE

Losartan Aurobindo 25 mg compresse rivestite con film NL/H/3056/001 043614015

AUROBINDO PHARMA (ITALIA) S.R.L. IT

Losartan Aurobindo 25 mg compresse rivestite con film NL/H/3056/001 043614027

AUROBINDO PHARMA (ITALIA) S.R.L. IT

Losartan Aurobindo 25 mg compresse rivestite con film NL/H/3056/001 043614039

AUROBINDO PHARMA (ITALIA) S.R.L. IT

Losartan Aurobindo 25 mg compresse rivestite con film NL/H/3056/001 043614041

AUROBINDO PHARMA (ITALIA) S.R.L. IT

List of nationally authorised medicinal products EMA/309956/2018 Page 3/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Losartan Aurobindo 25 mg compresse rivestite con film NL/H/3056/001 043614054

AUROBINDO PHARMA (ITALIA) S.R.L. IT

Cozaar® 25 mg film-coated tablets not available PL 0025/0336 MERCK SHARP & DOHME LTD. UK Neo-lotan 12,5 mg compresse rivestite con film not available 029385034 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 12,5 mg compresse rivestite con film not available 029385022 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 50 mg compresse rivestite con film not available 029385010 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 100 mg compresse rivestite con film not available 029385046 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 2.5 mg/ml polvere e solvente per sospensione orale not available 029385059 NEOPHARMED GENTILI S.R.L. IT Lortaan IC 12,5 mg comprimidos revestidos por película not available 3351582

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan IC 12,5 mg comprimidos revestidos por película not available 3351681

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 50 mg comprimidos revestidos por película not available 2356384

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 50 mg comprimidos revestidos por película not available 2356483

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 50 mg comprimidos revestidos por película not available 2356582

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 100 mg 100 mg comprimidos revestidos por película not available 4103982

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 100 mg 100 mg comprimidos revestidos por película not available 4104089

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 100 mg 100 mg comprimidos revestidos por película not available 4104188

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

Lortaan 100 mg 100 mg comprimidos revestidos por película not available 4104287

LABORATÓRIO MEDINFAR - PRODUTOS FARMACÊUTICOS, S.A. PT

COZAAR 50 mg επικαλυμμένα με λεπτό υμένιο δισκία NL/H/1457/002 16155 MERCK SHARP & DOHME BV CY COZAAR 100 mg επικαλυμμένα με λεπτό υμένιο δισκία NL/H/1457/003 19537 MERCK SHARP & DOHME BV CY COZAAR 12.5 mg επικαλυμμένα με λεπτό NL/H/1457/001 20464 MERCK SHARP & DOHME BV CY

List of nationally authorised medicinal products EMA/309956/2018 Page 4/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

υμένιο δισκία

Losartan Heumann 25 mg Filmtabletten - 72064.00.00 HEUMANN PHARMA GMBH & CO. GENERICA KG DE

Losartan-ratiopharm® 25 mg Filmtabletten DE/H/3505/002 86525.00.00 RATIOPHARM GMBH DE Losartan-ratiopharm® 12,5 mg Filmtabletten DE/H/3505/001 2014090254 RATIOPHARM GMBH LU Losartan-ratiopharm® 50 mg Filmtabletten DE/H/3505/003 2008040024 RATIOPHARM GMBH LU Losartan-ratiopharm® 25 mg Filmtabletten DE/H/3505/002 2014090255 RATIOPHARM GMBH LU Losartan-ratiopharm® 100 mg Filmtabletten DE/H/3505/005 2015120220 RATIOPHARM GMBH LU Losartan potassium 25 mg film-coated tablets not available PL 21880/0140 MEDREICH PLC UK Losartan potassium 50 mg film-coated tablets not available PL 21880/0141 MEDREICH PLC UK Losartan potassium 100 mg film-coated tablets not available PL 21880/0142 MEDREICH PLC UK Losartan potassium 12.5 mg film-coated tablets not available PL21880/0139 MEDREICH PLC UK LOSARTAN EUROGENERICI 25 mg compresse rivestite con film not available 039410016 EG S.P.A. IT Losartan-Kalium PUREN 25 mg Filmtabletten PT/H/1543/001 96040.00.00 PUREN PHARMA GMBH & CO. KG DE Losartán NORMON 25 mg Comprimidos recubiertos con película not available 67911 LABORATORIOS NORMON, S.A. ES Losanox 25 mg filmomhulde tabletten DK/H/0915/001 RVG 33624 LABORATORIOS LICONSA, S.A. NL

Cosaar 50 mg Filmtabletten NL/H/1457/002 1-21306 MERCK SHARP & DOHME GES.M.B.H. AT

Cosaar 100 mg Filmtabletten NL/H/1457/003 1-24232 MERCK SHARP & DOHME GES.M.B.H. AT

Cosaar 12,5 mg Filmtabletten NL/H/1457/001 1-22927 MERCK SHARP & DOHME GES.M.B.H. AT

Cozaar, 50 mg, comprimidos revestidos por película NL/H/1457/002 2317683 MERCK SHARP & DOHME, LDA. PT

List of nationally authorised medicinal products EMA/309956/2018 Page 5/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Cozaar, 50 mg, comprimidos revestidos por película NL/H/1457/002 2317584 MERCK SHARP & DOHME, LDA. PT

COZAAR 50 mg film-coated tablets NL/H/1457/002 PA1286/4/2 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

Cozaar, 50 mg, comprimidos revestidos por película NL/H/1457/002 2317782 MERCK SHARP & DOHME, LDA. PT Cozaar 50 mg filmomhulde tabletten NL/H/1457/002 RVG 17617 MERCK SHARP & DOHME BV NL Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982881 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982485 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982584 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982782 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982386 MERCK SHARP & DOHME, LDA. PT

COZAAR 100 mg film-coated tablets NL/H/1457/003 PA1286/4/3 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

Cozaar 100 mg filmomhulde tabletten NL/H/1457/003 RVG 26791 MERCK SHARP & DOHME BV NL Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982683 MERCK SHARP & DOHME, LDA. PT Cozaar IC, 12,5 mg, comprimidos revestidos por película NL/H/1457/001 3335080 MERCK SHARP & DOHME, LDA. PT Cozaar IC, 12,5 mg, comprimidos revestidos por película NL/H/1457/001 3335189 MERCK SHARP & DOHME, LDA. PT

COZAAR 12.5 mg film-coated tablets NL/H/1457/001 PA1286/4/1 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

Cozaar 12,5 mg filmomhulde tabletten NL/H/1457/001 RVG 101836 MERCK SHARP & DOHME BV NL Cozaar 2,5 mg/ml pó e solvente para suspensão oral NL/H/1457/004 5178207 MERCK SHARP & DOHME, LDA. PT Cozaar 2,5 mg/ml poeder en oplosmiddel voor orale suspensie NL/H/1457/004 RVG 103001 MERCK SHARP & DOHME BV NL COZAAR 2.5 mg/ml powder and solvent for oral suspension NL/H/1457/004 PA1286/4/4

MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

COZAAR 50 mg, comprimé pelliculé NL/H/1457/002 34009 343 350 9 9 MSD FRANCE FR

List of nationally authorised medicinal products EMA/309956/2018 Page 6/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

sécable COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 558 452 0 1 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 492 3 0 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 338 524 2 9 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 371 459 1 6 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 082 4 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 371 449 6 4 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 371 461 6 6 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 083 0 5 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 491 7 9 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 085 3 4 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 087 6 3 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 371 458 5 5 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 495 2 0 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 088 2 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 371 447 3 5 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 358 495 8 8 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 371 450 4 6 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 494 6 9 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 084 7 3 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 574 496 9 8 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 095 9 3 MSD FRANCE FR

List of nationally authorised medicinal products EMA/309956/2018 Page 7/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 091 3 5 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 093 6 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 563 580 3 8 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 090 7 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 089 9 2 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 574 497 5 9 MSD FRANCE FR COZAAR 2,5 mg/ml, poudre et solvant pour suspension buvable NL/H/1457/004 34009 393 134 8 1 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 094 2 5 MSD FRANCE FR Losar Teva® 25 mg Filmtabletten Wirkstoff: Losartan-Kalium DE/H/0848/002 66960.00.00 TEVA GMBH DE Losartan-AbZ 25 mg Filmtabletten DE/H/3571/002 87048.00.00 ABZ-PHARMA GMBH DE Cozaar® 2,5 mg/ml Pulver und Lösungsmittel zur Herstellung einer Suspension zum Einnehmen NL/H/1457/004 BE334521 MSD BELGIUM BVBA/SPRL BE COZAAR® 12,5 mg, Filmtabletten NL/H/1457/001 BE341031 MSD BELGIUM BVBA/SPRL BE COZAAR® 12,5 mg, Filmtabletten NL/H/1457/001 BE201144 MSD BELGIUM BVBA/SPRL BE COZAAR® 50 mg, Filmtabletten NL/H/1457/002 BE341047 MSD BELGIUM BVBA/SPRL BE COZAAR® 50 mg, Filmtabletten NL/H/1457/002 BE173074 MSD BELGIUM BVBA/SPRL BE COZAAR® 100 mg, Filmtabletten NL/H/1457/003 BE341056 MSD BELGIUM BVBA/SPRL BE COZAAR® 100 mg, Filmtabletten NL/H/1457/003 BE235627 MSD BELGIUM BVBA/SPRL BE Cozaar® 50 mg filmomhulde tabletten NL/H/1457/002 BE341047 MSD BELGIUM BVBA/SPRL BE Cozaar® 50 mg filmomhulde tabletten NL/H/1457/002 BE173074 MSD BELGIUM BVBA/SPRL BE Cozaar® 50 mg, comprimés pelliculés NL/H/1457/002 BE173074 MSD BELGIUM BVBA/SPRL BE Cozaar® 50 mg, comprimés pelliculés NL/H/1457/002 BE341047 MSD BELGIUM BVBA/SPRL BE Cozaar® 100 mg, comprimés pelliculés NL/H/1457/003 BE341056 MSD BELGIUM BVBA/SPRL BE Cozaar® 100 mg, comprimés pelliculés NL/H/1457/003 BE235627 MSD BELGIUM BVBA/SPRL BE COZAAR® 100 mg filmomhulde tabletten NL/H/1457/003 BE341056 MSD BELGIUM BVBA/SPRL BE COZAAR® 100 mg filmomhulde tabletten NL/H/1457/003 BE235627 MSD BELGIUM BVBA/SPRL BE Cozaar® 12,5 mg filmomhulde tabletten NL/H/1457/001 BE201144 MSD BELGIUM BVBA/SPRL BE Cozaar® 12,5 mg, comprimés pelliculés NL/H/1457/001 BE201144 MSD BELGIUM BVBA/SPRL BE Cozaar® 12,5 mg filmomhulde tabletten NL/H/1457/001 BE341031 MSD BELGIUM BVBA/SPRL BE Cozaar® 12,5 mg, comprimés pelliculés NL/H/1457/001 BE341031 MSD BELGIUM BVBA/SPRL BE COZAAR® 2,5 mg/ml, poudre et solvant pour suspension buvable NL/H/1457/004 BE334521 MSD BELGIUM BVBA/SPRL BE

List of nationally authorised medicinal products EMA/309956/2018 Page 8/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

COZAAR® 2,5 mg/ml poeder en oplosmiddel voor orale suspensie NL/H/1457/004 BE334521 MSD BELGIUM BVBA/SPRL BE LOSAPREX 2,5 mg/ml polvere e solvente per sospensione orale not available 029393055 ALFASIGMA S.P.A. IT LOSAPREX 100 mg compresse rivestite con film NL/H/1457/003 029393042 ALFASIGMA S.P.A. IT LOSAPREX 12,5 mg compresse rivestite con film NL/H/1457/001 029393030 ALFASIGMA S.P.A. IT LOSAPREX 12,5 mg compresse rivestite con film NL/H/1457/001 029393028 ALFASIGMA S.P.A. IT LOSAPREX 50 mg compresse rivestite con film NL/H/1457/002 029393016 ALFASIGMA S.P.A. IT Cozaar 100 mg comprimidos recubiertos con película NL/H/1457/003 64.971

MERCK SHARP & DOHME DE ESPAÑA, S.A ES

Cozaar® 2,5 mg/ml Pulver und Lösungsmittel zur Herstellung einer Suspension zum Einnehmen NL/H/1457/004 BE334521 MSD BELGIUM BVBA/SPRL BE COZAAR® 12,5 mg, Filmtabletten NL/H/1457/001 BE341031 MSD BELGIUM BVBA/SPRL BE COZAAR® 12,5 mg, Filmtabletten NL/H/1457/001 BE201144 MSD BELGIUM BVBA/SPRL BE Cozaar 100 mg filmdragerade tabletter NL/H/1457/003 16602 MERCK SHARP & DOHME BV FI Cozaar 12,5 mg filmdragerade tabletter NL/H/1457/001 12916 MERCK SHARP & DOHME BV FI Cozaar 50 mg filmdragerade tabletter NL/H/1457/002 11637 MERCK SHARP & DOHME BV FI COZAAR® 50 mg, Filmtabletten NL/H/1457/002 BE341047 MSD BELGIUM BVBA/SPRL BE COZAAR® 50 mg, Filmtabletten NL/H/1457/002 BE173074 MSD BELGIUM BVBA/SPRL BE COZAAR® 100 mg, Filmtabletten NL/H/1457/003 BE341056 MSD BELGIUM BVBA/SPRL BE COZAAR® 100 mg, Filmtabletten NL/H/1457/003 BE235627 MSD BELGIUM BVBA/SPRL BE

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/030 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/011 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/001 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/029 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cosaar 50 mg Filmtabletten NL/H/1457/002 1-21306 MERCK SHARP & DOHME GES.M.B.H. AT

List of nationally authorised medicinal products EMA/309956/2018 Page 9/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Cosaar 100 mg Filmtabletten NL/H/1457/003 1-24232 MERCK SHARP & DOHME GES.M.B.H. AT

Cosaar 12,5 mg Filmtabletten NL/H/1457/001 1-22927 MERCK SHARP & DOHME GES.M.B.H. AT

COZAAR® 50 mg, comprimés pelliculés NL/H/1457/002 1995040196 MSD BELGIUM BVBA/SPRL LU

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/01 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/02 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/03 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/04 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/05 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar, 50 mg, comprimidos revestidos por película NL/H/1457/002 2317683 MERCK SHARP & DOHME, LDA. PT Cozaar® 50 mg filmomhulde tabletten NL/H/1457/002 BE341047 MSD BELGIUM BVBA/SPRL BE

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/06 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg tablett, filmdrasjert NL/H/1457/002 00-8059 MERCK SHARP & DOHME BV NO Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/26 MSD PHARMA HUNGARY KFT. HU COZAAR, 50 mg, tabletki powlekane NL/H/1457/002 R/6744 MSD POLSKA SP. Z O.O. PL Cozaar, 50 mg, comprimidos revestidos por película NL/H/1457/002 2317584 MERCK SHARP & DOHME, LDA. PT

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/07 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/23 MSD PHARMA HUNGARY KFT. HU

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/08 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/09 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg kalvopäällysteiset tabletit NL/H/1457/002 11637 MERCK SHARP & DOHME BV FI Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/18 MSD PHARMA HUNGARY KFT. HU Cozaar® 50 mg filmomhulde tabletten NL/H/1457/002 BE173074 MSD BELGIUM BVBA/SPRL BE Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/21 MSD PHARMA HUNGARY KFT. HU

List of nationally authorised medicinal products EMA/309956/2018 Page 10/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/14 MSD PHARMA HUNGARY KFT. HU

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/10 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/15 MSD PHARMA HUNGARY KFT. HU Cozaar® 50 mg, comprimés pelliculés NL/H/1457/002 BE173074 MSD BELGIUM BVBA/SPRL BE Lortaan 50 mg compresse rivestite con film NL/H/1457/002 029384017 MSD ITALIA S.R.L. IT

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/11 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/13 MSD PHARMA HUNGARY KFT. HU

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/12 MERCK SHARP & DOHME ROMANIA SRL RO

LORZAAR® PROTECT 50 mg Filmtabletten Wirkstoff: Losartan-Kalium NL/H/1457/002 41546.01.00 MSD SHARP & DOHME GMBH DE Cozaar® 50 mg film-coated tablets NL/H/1457/002 PL 0025/0324 MERCK SHARP & DOHME LTD. UK Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/12 MSD PHARMA HUNGARY KFT. HU

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/13 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/17 MSD PHARMA HUNGARY KFT. HU Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/20 MSD PHARMA HUNGARY KFT. HU Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/16 MSD PHARMA HUNGARY KFT. HU

COZAAR 50 mg film-coated tablets NL/H/1457/002 PA1286/4/2 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/14 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmdragerade tabletter NL/H/1457/002 12209 MERCK SHARP & DOHME BV SE

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/15 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar, 50 mg, comprimidos revestidos por película NL/H/1457/002 2317782 MERCK SHARP & DOHME, LDA. PT Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/24 MSD PHARMA HUNGARY KFT. HU

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/16 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/19 MSD PHARMA HUNGARY KFT. HU Cozaar® 50 mg, comprimés pelliculés NL/H/1457/002 BE341047 MSD BELGIUM BVBA/SPRL BE COZAAR 50 mg filmuhúðaðar töflur NL/H/1457/002 930306 MERCK SHARP & DOHME BV IS

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/17 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg filmomhulde tabletten NL/H/1457/002 RVG 17617 MERCK SHARP & DOHME BV NL Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/25 MSD PHARMA HUNGARY KFT. HU Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/22 MSD PHARMA HUNGARY KFT. HU COZAAR 50 mg film-coated tablets NL/H/1457/002 MA058/01302 MERCK SHARP & DOHME LTD. MT

COZAAR 50 mg comprimate filmate NL/H/1457/002 2977/2010/18 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 50 mg comprimidos recubiertos con película NL/H/1457/002 60.913

MERCK SHARP & DOHME DE ESPAÑA, S.A ES

COZAAR, 100 mg, tabletki powlekane NL/H/1457/003 10734 MSD POLSKA SP. Z O.O. PL Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982881 MERCK SHARP & DOHME, LDA. PT COZAAR 100 mg film-coated tablets NL/H/1457/003 MA058/01303 MERCK SHARP & DOHME LTD. MT Cozaar 100 mg filmdragerade tabletter NL/H/1457/003 17386 MERCK SHARP & DOHME BV SE Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/34 MSD PHARMA HUNGARY KFT. HU Lortaan 100 mg compresse rivestite con film NL/H/1457/003 029384043 MSD ITALIA S.R.L. IT Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982485 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/31 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/37 MSD PHARMA HUNGARY KFT. HU Cozaar® 100 mg, comprimés pelliculés NL/H/1457/003 BE341056 MSD BELGIUM BVBA/SPRL BE Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/27 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982584 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg kalvopäällysteiset tabletit NL/H/1457/003 16602 MERCK SHARP & DOHME BV FI Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982782 MERCK SHARP & DOHME, LDA. PT Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982386 MERCK SHARP & DOHME, LDA. PT

COZAAR 100 mg film-coated tablets NL/H/1457/003 PA1286/4/3 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/30 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/40 MSD PHARMA HUNGARY KFT. HU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Cozaar® 100 mg, comprimés pelliculés NL/H/1457/003 BE235627 MSD BELGIUM BVBA/SPRL BE Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/38 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/35 MSD PHARMA HUNGARY KFT. HU COZAAR 100 mg filmuhúðaðar töflur NL/H/1457/003 IS/1/02/103/01 MERCK SHARP & DOHME BV IS COZAAR® 100 mg filmomhulde tabletten NL/H/1457/003 BE341056 MSD BELGIUM BVBA/SPRL BE Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/39 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/29 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/36 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg tablett, filmdrasjert NL/H/1457/003 01-6335 MERCK SHARP & DOHME BV NO Cozaar 100 mg filmomhulde tabletten NL/H/1457/003 RVG 26791 MERCK SHARP & DOHME BV NL Cozaar® 100 mg film-coated tablets NL/H/1457/003 PL 0025/0416 MERCK SHARP & DOHME LTD. UK Cozaar 100 mg, 100 mg, comprimidos revestidos por película NL/H/1457/003 3982683 MERCK SHARP & DOHME, LDA. PT LORZAAR® PROTECT 100 mg Filmtabletten Wirkstoff: Losartan-Kalium NL/H/1457/003 41546.02.00 MSD SHARP & DOHME GMBH DE Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/28 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/32 MSD PHARMA HUNGARY KFT. HU COZAAR® 100 mg filmomhulde tabletten NL/H/1457/003 BE235627 MSD BELGIUM BVBA/SPRL BE Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/33 MSD PHARMA HUNGARY KFT. HU COZAAR® 100 mg, comprimés pelliculés NL/H/1457/003 2007019153 MSD BELGIUM BVBA/SPRL LU Cozaar IC, 12,5 mg, comprimidos revestidos por película NL/H/1457/001 3335080 MERCK SHARP & DOHME, LDA. PT

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/01 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/04 MSD PHARMA HUNGARY KFT. HU

КОЗАР 12,5 mg филмирани таблетки NL/H/1457/001 20090151 MERCK SHARP & DOHME BULGARIA EOOD BG

Cozaar® 12,5 mg filmomhulde tabletten NL/H/1457/001 BE201144 MSD BELGIUM BVBA/SPRL BE Lortaan 12,5 mg compresse rivestite con film NL/H/1457/001 029384031 MSD ITALIA S.R.L. IT

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/02 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/03 MERCK SHARP & DOHME ROMANIA SRL RO

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/04 MERCK SHARP & DOHME RO

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

ROMANIA SRL Cozaar® 12,5 mg, comprimés pelliculés NL/H/1457/001 BE201144 MSD BELGIUM BVBA/SPRL BE

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/05 MERCK SHARP & DOHME ROMANIA SRL RO

Lortaan 12,5 mg compresse rivestite con film NL/H/1457/001 029384029 MSD ITALIA S.R.L. IT Cozaar 12,5 mg kalvopäällysteiset tabletit NL/H/1457/001 12916 MERCK SHARP & DOHME BV FI COZAAR 12.5 mg film-coated tablets NL/H/1457/001 MA058/01305 MERCK SHARP & DOHME LTD. MT Cozaar® 12,5 mg filmomhulde tabletten NL/H/1457/001 BE341031 MSD BELGIUM BVBA/SPRL BE COZAAR 12,5 mg filmuhúðaðar töflur NL/H/1457/001 970239 MERCK SHARP & DOHME BV IS Cozaar® 12,5 mg, comprimés pelliculés NL/H/1457/001 BE341031 MSD BELGIUM BVBA/SPRL BE COZAAR, 12,5 mg, tabletki powlekane NL/H/1457/001 9978 MSD POLSKA SP. Z O.O. PL Cozaar 12,5 mg filmdragerade tabletter NL/H/1457/001 13718 MERCK SHARP & DOHME BV SE

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/06 MERCK SHARP & DOHME ROMANIA SRL RO

LORZAAR® START 12,5 mg Filmtabletten Wirkstoff: Losartan-Kalium NL/H/1457/001 41542.00.00 MSD SHARP & DOHME GMBH DE

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/07 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar, filmovertrukne tabletter NL/H/1457/001 18978 MERCK SHARP & DOHME BV DK Cozaar IC, 12,5 mg, comprimidos revestidos por película NL/H/1457/001 3335189 MERCK SHARP & DOHME, LDA. PT Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/07 MSD PHARMA HUNGARY KFT. HU Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/06 MSD PHARMA HUNGARY KFT. HU Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/01 MSD PHARMA HUNGARY KFT. HU

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/08 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/10 MSD PHARMA HUNGARY KFT. HU

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/09 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/05 MSD PHARMA HUNGARY KFT. HU

COZAAR 12,5 mg comprimate filmate NL/H/1457/001 2976/2010/10 MERCK SHARP & DOHME ROMANIA SRL RO

Cozaar® 12.5 mg film-coated tablets NL/H/1457/001 PL 0025/0515 MERCK SHARP & DOHME LTD. UK COZAAR® 12,5 mg, comprimés pelliculés NL/H/1457/001 1999060006 MSD BELGIUM BVBA/SPRL LU

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

COZAAR 12.5 mg film-coated tablets NL/H/1457/001 PA1286/4/1 MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/11 MSD PHARMA HUNGARY KFT. HU Cozaar 12,5 mg INICIO comprimidos recubiertos con película NL/H/1457/001 62.117

MERCK SHARP & DOHME DE ESPAÑA, S.A ES

Cozaar 12,5 mg filmomhulde tabletten NL/H/1457/001 RVG 101836 MERCK SHARP & DOHME BV NL Cozaar 12,5 mg tablett, filmdrasjert NL/H/1457/001 97-2003 MERCK SHARP & DOHME BV NO Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/08 MSD PHARMA HUNGARY KFT. HU Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/09 MSD PHARMA HUNGARY KFT. HU COZAAR® 2.5 mg/ml powder and solvent for oral suspension NL/H/1457/004 PL 00025/0530 MERCK SHARP & DOHME LTD. UK COZAAR® 2,5 mg/ml, poudre et solvant pour suspension buvable NL/H/1457/004 2009030031 MSD BELGIUM BVBA/SPRL LU Cozaar 2,5 mg/ml pó e solvente para suspensão oral NL/H/1457/004 5178207 MERCK SHARP & DOHME, LDA. PT Cozaar 2,5 mg/ml poeder en oplosmiddel voor orale suspensie NL/H/1457/004 RVG 103001 MERCK SHARP & DOHME BV NL COZAAR 2.5 mg/ml powder and solvent for oral suspension NL/H/1457/004 PA1286/4/4

MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LTD IE

COZAAR® 2,5 mg/ml, poudre et solvant pour suspension buvable NL/H/1457/004 BE334521 MSD BELGIUM BVBA/SPRL BE LORTAAN 2,5 mg/ml polvere e solvente per sospensione orale NL/H/1457/004 029384056 MSD ITALIA S.R.L. IT LORZAAR® 2,5 mg/ml Pulver und Lösungsmittel zur Herstellung einer Suspension zum Einnehmen Wirkstoff: Losartan-Kalium NL/H/1457/004 77187.00.00 MSD SHARP & DOHME GMBH DE COZAAR 2,5 mg/ml mixtúruduft og leysir, dreifa NL/H/1457/004 IS/1/09/063/01 MERCK SHARP & DOHME BV IS Cozaar 2,5 mg/ml pulver og væske til mikstur, suspensjon NL/H/1457/004 09-6574 MERCK SHARP & DOHME BV NO COZAAR® 2,5 mg/ml poeder en oplosmiddel voor orale suspensie NL/H/1457/004 BE334521 MSD BELGIUM BVBA/SPRL BE Cozaar, filmovertrukne tabletter NL/H/1457/002 15844 MERCK SHARP & DOHME BV DK COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 343 350 9 9 MSD FRANCE FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 558 452 0 1 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 492 3 0 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 338 524 2 9 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 371 459 1 6 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 082 4 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 371 449 6 4 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 371 461 6 6 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 083 0 5 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 491 7 9 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 085 3 4 MSD FRANCE FR Cozaar, filmovertrukne tabletter NL/H/1457/003 32842 MERCK SHARP & DOHME BV DK COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 087 6 3 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 371 458 5 5 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 495 2 0 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 088 2 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 371 447 3 5 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 358 495 8 8 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 371 450 4 6 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 574 494 6 9 MSD FRANCE FR COZAAR 50 mg, comprimé pelliculé sécable NL/H/1457/002 34009 392 084 7 3 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 574 496 9 8 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 095 9 3 MSD FRANCE FR

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 091 3 5 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 093 6 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 563 580 3 8 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 090 7 4 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 089 9 2 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 574 497 5 9 MSD FRANCE FR COZAAR 2,5 mg/ml, poudre et solvant pour suspension buvable NL/H/1457/004 34009 393 134 8 1 MSD FRANCE FR COZAAR 100 mg, comprimé pelliculé NL/H/1457/003 34009 392 094 2 5 MSD FRANCE FR COZAAR® 50 mg, potahované tablety NL/H/1457/002 58/607/08-C MERCK SHARP & DOHME BV CZ COZAAR® 100 mg, potahované tablety NL/H/1457/003 58/608/08-C MERCK SHARP & DOHME BV CZ

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/002 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/003 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/004 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/005 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/006 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/007 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/008 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/009 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 12,5 mg filmsko obložene tablete NL/H/1457/001 H/95/00429/010 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/012 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/013 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/014 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/015 MERCK SHARP & DOHME SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

INOVATIVNA ZDRAVILA D.O.O.

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/016 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/017 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/018 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/019 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/020 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/021 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/022 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/023 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/024 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/025 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/026 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/027 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 50 mg filmsko obložene tablete NL/H/1457/002 H/95/00429/028 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/031 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/032 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/033 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/034 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/035 MERCK SHARP & DOHME SI

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

INOVATIVNA ZDRAVILA D.O.O.

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/036 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/037 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/038 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/039 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/040 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/041 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/042 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/043 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/044 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

Cozaar 100 mg filmsko obložene tablete NL/H/1457/003 H/95/00429/045 MERCK SHARP & DOHME INOVATIVNA ZDRAVILA D.O.O. SI

COZAAR 12.5 mg επικαλυμμένα με λεπτό υμένιο δισκία. NL/H/1457/001 40422/31-05-2013 VIANEX S.A. GR COZAAR 50 mg επικαλυμμένα με λεπτό υμένιο δισκία NL/H/1457/002 38346/31-05-2013 VIANEX S.A. GR COZAAR 100 mg επικαλυμμένα με λεπτό υμένιο δισκία NL/H/1457/003 43376/ 31-05-2013 VIANEX S.A. GR Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/43 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/47 MSD PHARMA HUNGARY KFT. HU Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/44 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/45 MSD PHARMA HUNGARY KFT. HU Cozaar 12,5 mg filmtabletta NL/H/1457/001 OGYI-T-6454/41 MSD PHARMA HUNGARY KFT. HU Cozaar 100 mg filmtabletta NL/H/1457/003 OGYI-T-6454/46 MSD PHARMA HUNGARY KFT. HU Cozaar 50 mg filmtabletta NL/H/1457/002 OGYI-T-6454/42 MSD PHARMA HUNGARY KFT. HU Losartan-CT 25 mg Filmtabletten DE/H/3570/002 87044.00.00 ABZ-PHARMA GMBH DE Losartán ratio 25 mg comprimidos DE/H/3570/002 78.475 RATIOPHARM ESPANA SA ES

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

recubiertos con película Losartán ratio 100 mg comprimidos recubiertos con película EFG DE/H/3570/005 79923 RATIOPHARM ESPANA SA ES Losatrix 50 mg filmuhúðaðar töflur. UK/H/0925/003 IS/1/13/093/02 RATIOPHARM GMBH IS Losatrix 25 mg filmuhúðaðar töflur. UK/H/0925/002 IS/1/13/093/01 RATIOPHARM GMBH IS Losatrix 100 mg filmuhúðaðar töflur. UK/H/0925/004 IS/1/13/093/03 RATIOPHARM GMBH IS Arbartan 100 mg filmtabletta UK/H/0925/004 OGYI-T-20536/07 TEVA GYÓGYSZERGYÁR ZRT HU Arbartan 25 mg filmtabletta UK/H/0925/002 OGYI-T-20536/01 TEVA GYÓGYSZERGYÁR ZRT HU Arbartan 50 mg filmtabletta UK/H/0925/003 OGYI-T-20536/04 TEVA GYÓGYSZERGYÁR ZRT HU Losartan ratiopharm 100 mg Filmtabletten UK/H/0925/004 1-27322 TEVA B.V AT Losartan ratiopharm 25 mg Filmtabletten UK/H/0925/002 1-27320 TEVA B.V AT Losartan ratiopharm 50 mg Filmtabletten UK/H/0925/003 1-27321 TEVA B.V AT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038112064 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038112052 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038112049 TEVA ITALIA S.R.L. IT Losartan Teva 100 mg compresse rivestite con film UK/H/0925/004 038112254 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038112203 TEVA ITALIA S.R.L. IT Losatrix 100 mg kalvopäällysteiset tabletit UK/H/0925/004 22360 RATIOPHARM GMBH FI Losartan Teva 100 mg compresse rivestite con film UK/H/0925/004 038112278 TEVA ITALIA S.R.L. IT Losartan Teva 100 mg compresse rivestite con film UK/H/0925/004 038112266 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038112215 TEVA ITALIA S.R.L. IT Losatrix 50 mg kalvopäällysteiset tabletit UK/H/0925/003 22359 RATIOPHARM GMBH FI Losatrix 25 mg kalvopäällysteiset tabletit UK/H/0925/002 22358 RATIOPHARM GMBH FI Losartan Teva 50 mg compresse rivestite con film UK/H/0925/003 038112241 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite UK/H/0925/002 038112191 TEVA ITALIA S.R.L. IT

List of nationally authorised medicinal products EMA/309956/2018 Page 20/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

con film Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 38112049 TEVA ITALIA S.R.L. IT Losartan Teva 50 mg compresse rivestite con film UK/H/0925/003 038112227 TEVA ITALIA S.R.L. IT Losartan Teva 50 mg compresse rivestite con film UK/H/0925/003 038112239 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098226 TEVA ITALIA S.R.L. IT Losartan Teva 100 mg tabletter, filmdrasjerte UK/H/0925/004 06-4223 TEVA SWEDEN AB NO Losartan potassium 25 mg Film-coated Tablets UK/H/0925/002 PL 00289/0963 TEVA UK LIMITED UK Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098012 TEVA ITALIA S.R.L. IT Losartan Teva 50 mg tabletter, filmdrasjerte UK/H/0925/003 06-4222 TEVA SWEDEN AB NO Losatrix 100 mg kalvopäällysteiset tabletit UK/H/0925/004 22360 RATIOPHARM GMBH FI Losartankalium ”Teva”, filmovertrukne tabletter UK/H/0925/003 39586 TEVA DENMARK A/S DK Losatrix 25 mg kalvopäällysteiset tabletit UK/H/0925/002 22358 RATIOPHARM GMBH FI Losartan Teva 25 mg tabletter, filmdrasjerte UK/H/0925/002 06-4221 TEVA SWEDEN AB NO Losartan Teva 50 mg filmdragerade tabletter UK/H/0925/003 24078 TEVA SWEDEN AB SE Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098125 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098024 TEVA ITALIA S.R.L. IT LOSARTAN TEVA 100 mg, comprimé pelliculé sécable UK/H/0925/004 NL33084 TEVA SANTÉ FR Losartan Teva 100 mg filmdragerade tabletter UK/H/0925/004 24079 TEVA SWEDEN AB SE Losartankalium ”Teva”, filmovertrukne tabletter UK/H/0925/004 39587 TEVA DENMARK A/S DK

List of nationally authorised medicinal products EMA/309956/2018 Page 21/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098214 TEVA ITALIA S.R.L. IT LOSARTAN TEVA 50 mg, comprimé pelliculé sécable UK/H/0925/003 NL33083 TEVA SANTÉ FR Losatrix 50 mg kalvopäällysteiset tabletit UK/H/0925/003 22359 RATIOPHARM GMBH FI Losartan Potassium 100 mg Film-coated Tablets UK/H/0925/004 PL 00289/0965 TEVA UK LIMITED UK

Losartan ratiopharm, 50 mg, comprimidos revestidos por película UK/H/0925/003 5089701

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098277 TEVA ITALIA S.R.L. IT

Losartan ratiopharm, 100 mg, comprimidos revestidos por película UK/H/0925/004 5089651

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan ratiopharm, 100 mg, comprimidos revestidos por película UK/H/0925/004 5089669

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098137 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098190 TEVA ITALIA S.R.L. IT Losartan potassium 50 mg Film-coated Tablets UK/H/0925/003 PL 00289/0964 TEVA UK LIMITED UK Losartankalium 25 mg PCH, filmomhulde tabletten UK/H/0925/002 RVG 34188 PHARMACHEMIE B.V NL Losartankalium 50 mg PCH, filmomhulde tabletten UK/H/0925/003 RVG 34189 PHARMACHEMIE B.V NL Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098149 TEVA ITALIA S.R.L. IT Losartankalium 100 mg PCH, filmomhulde tabletten UK/H/0925/004 RVG 34190 PHARMACHEMIE B.V NL Arbartan 25 mg filmtabletta UK/H/0925/002 OGYI-T-20536/03 TEVA GYÓGYSZERGYÁR ZRT HU Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098063 TEVA ITALIA S.R.L. IT Losartan ratiopharm, 50 mg, UK/H/0925/003 5089644 RATIOPHARM-COMERCIO E PT

List of nationally authorised medicinal products EMA/309956/2018 Page 22/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

comprimidos revestidos por película INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098036 TEVA ITALIA S.R.L. IT Arbartan 50 mg filmtabletta UK/H/0925/003 OGYI-T-20536/06 TEVA GYÓGYSZERGYÁR ZRT HU Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098238 TEVA ITALIA S.R.L. IT

Losartan ratiopharm, 100 mg, comprimidos revestidos por película UK/H/0925/004 5089727

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098289 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098101 TEVA ITALIA S.R.L. IT

Losartan ratiopharm, 100 mg, comprimidos revestidos por película UK/H/0925/004 5089610

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098291 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098099 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098152 TEVA ITALIA S.R.L. IT

Losartan ratiopharm, 50 mg, comprimidos revestidos por película UK/H/0925/003 5089602

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan ratiopharm, 50 mg, comprimidos revestidos por película UK/H/0925/003 5089578

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098048 TEVA ITALIA S.R.L. IT

Losartan ratiopharm, 50 mg, comprimidos revestidos por película UK/H/0925/003 5089677

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098253 TEVA ITALIA S.R.L. IT

List of nationally authorised medicinal products EMA/309956/2018 Page 23/24

Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098075 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098051 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098176 TEVA ITALIA S.R.L. IT

Losartan ratiopharm, 100 mg, comprimidos revestidos por película UK/H/0925/004 5089719

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan ratiopharm, 100 mg, comprimidos revestidos por película UK/H/0925/004 5089628

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098265 TEVA ITALIA S.R.L. IT Arbartan 50 mg filmtabletta UK/H/0925/003 OGYI-T-20536/05 TEVA GYÓGYSZERGYÁR ZRT HU Arbartan 100 mg filmtabletta UK/H/0925/004 OGYI-T-20536/09 TEVA GYÓGYSZERGYÁR ZRT HU

Losartan ratiopharm, 50 mg, comprimidos revestidos por película UK/H/0925/003 5089636

RATIOPHARM-COMERCIO E INDUSTRIA DE PRODUTOS FARMACEUTICOS LDA PT

Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098087 TEVA ITALIA S.R.L. IT Arbartan 25 mg filmtabletta UK/H/0925/002 OGYI-T-20536/02 TEVA GYÓGYSZERGYÁR ZRT HU Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098303 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098240 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098164 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098113 TEVA ITALIA S.R.L. IT Arbartan 100 mg filmtabletta UK/H/0925/004 OGYI-T-20536/08 TEVA GYÓGYSZERGYÁR ZRT HU Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098188 TEVA ITALIA S.R.L. IT Losartan Teva 25 mg compresse rivestite con film UK/H/0925/002 038098202 TEVA ITALIA S.R.L. IT Neo-lotan 12,5 mg compresse rivestite not available 029385034 NEOPHARMED GENTILI S.R.L. IT

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Product Name (in authorisation country)

MRP/DCP Authorisation number

National Authorisation Number

MAH of product in the member state

Member State where product is authorised

con film Neo-lotan 12,5 mg compresse rivestite con film not available 029385022 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 50 mg compresse rivestite con film not available 029385010 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 100 mg compresse rivestite con film not available 029385046 NEOPHARMED GENTILI S.R.L. IT Neo-lotan 2.5 mg/ml polvere e solvente per sospensione orale not available 029385059 NEOPHARMED GENTILI S.R.L. IT Losartan ”Aurobindo”, filmovertrukne tabletter NL/H/3056/001 54075

AUROBINDO PHARMA (MALTA) LIMITED DK

Losartankalium Aurobindo 25 mg, filmomhulde tabletten NL/H/3056/001 RVG 105815 AUROBINDO PHARMA B.V. NL Losartán Aurobindo 25 mg comprimidos recubiertos con película NL/H/3056/001 79.245 LABORATORIOS AUROBINDO S.L.U. ES LOSAPREX 2,5 mg/ml polvere e solvente per sospensione orale not available 029393055 ALFASIGMA S.P.A. IT LOSAPREX 100 mg compresse rivestite con film NL/H/1457/003 029393042 ALFASIGMA S.P.A. IT LOSAPREX 12,5 mg compresse rivestite con film NL/H/1457/001 029393030 ALFASIGMA S.P.A. IT LOSAPREX 12,5 mg compresse rivestite con film NL/H/1457/001 029393028 ALFASIGMA S.P.A. IT LOSAPREX 50 mg compresse rivestite con film NL/H/1457/002 029393016 ALFASIGMA S.P.A. IT